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Name of the Trial
Phase III Randomized Study of Operative Debulking and Systemic Chemotherapy with or without Intra- and Peri-Operative Intraperitoneal Chemotherapy in Patients with Peritoneal Carcinomatosis from Low-Grade Gastrointestinal Adenocarcinoma (NCI-03-C-0085). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-03-C-0085.

Principal Investigator
Dr. James Pingpank, NCI Center for Cancer Research

Why This Trial Is Important
Peritoneal carcinomatosis is a rare type of metastatic cancer in which tumors form throughout the peritoneum, the membrane that lines the abdominal cavity. Several types of cancer may cause peritoneal carcinomatosis, but it is often associated with gastrointestinal cancers. Without aggressive treatment, peritoneal carcinomatosis is almost always fatal.

In this clinical trial, patients with peritoneal carcinomatosis from low-grade gastrointestinal cancers will be treated with surgery to remove all visible tumors (operative debulking). During surgery, half of the patients will also be treated with hyperthermic chemotherapy administered directly into the peritoneal cavity (continuous hyperthermic peritoneal perfusion). These patients will receive additional intraperitoneal chemotherapy within 2 weeks after surgery. All patients will receive systemic chemotherapy 4 to 6 weeks after surgery.

Researchers hope to determine whether adding continuous hyperthermic peritoneal perfusion to operative debulking will help delay the progression of peritoneal carcinomatosis and result in longer survival.

"Many patients with low-grade gastrointestinal carcinomas develop peritoneal carcinomatosis rather than distant metastases," said Dr. Pingpank. "We know the most important aspect of treatment for these patients is complete resection of the tumors. What we hope to determine is whether adding the intraperitoneal perfusion will provide an added benefit that would justify the potential toxicity of the procedure."

Who Can Join This Trial
Researchers will recruit 82 patients aged 18 and over with peritoneal carcinomatosis arising from low-grade gastrointestinal adenocarcinoma. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/NCI-03-C-0085.

Study Site and Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is completely confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.